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. 2023 Feb 3;2023(2):CD013267. doi: 10.1002/14651858.CD013267.pub3

Cui 2016.

Study name Angioplasty and stenting for patients with symptomatic intracranial atherosclerosis
Methods Multicentre randomised trial in 3 high‐volume centres
Participants Estimated sample size: 539
Inclusion criteria
  • Age 40–70 years

  • ≥ 3 TIAs or 1 ischaemic stroke

  • 70%–99% stenosis of intracranial carotid artery or MCA under maximal dosage of medical management

  • Cerebral hypoperfusion in the territory of target vessels


Exclusion criteria
  • CT or MRI evidence of massive cerebral infarction

  • Cerebral infarction caused by perforator occlusion

  • Previous stent or angioplasty in the target lesion

  • Progressive neurological signs within 24 hours before enrolment

  • Haemorrhagic infarction within 14 days before enrolment

  • Cardiac source of embolus

  • Thrombolytic therapy within 24 hours before enrolment

  • Intraluminal thrombus proximal to or at the target lesion

  • Myocardial infarction within 30 days before enrolment

  • Non‐atherosclerotic stenosis

Interventions PTAS plus aggressive medical management after ≥ 3 weeks versus aggressive medical management alone
Outcomes Primary outcome
  • Incidence of ipsilateral stroke (including haemorrhagic or ischaemic stroke) or death at 30 days after randomisation


Secondary outcomes
  • Incidence of recurrent ischaemic stroke in the stenting‐involved vascular territory at 30 days, 3 months, and 12 months after randomisation

  • Rate of participants with residual stenosis < 30% at 3 and 12 months after randomisation

  • Incidence of in‐stent restenosis at 12 months after randomisation

  • Incidence of cerebral parenchymal, subarachnoid, or intraventricular haemorrhage at 30 days, 3 months, and 12 months after randomisation

  • Incidence of myocardial infarction or major non‐stroke haemorrhage (epidural or subdural haemorrhage or haemorrhage in major organs) at 30 days after randomisation

  • C‐NIHSS: 28; mRS: 29; and CSQoL30 at 30 days, 3 months, and 12 months after randomisation

Starting date April 2016
Contact information ClinicalTrials.gov identifier: NCT02689037.
More details in the published protocol: DOI: 10.1136/bmjopen‐2016‐012175
Notes This study is financially supported by a Health Research Fund from People's Liberation Army (No. 12MA100). The study sponsor and funders play no role in study design, collection, management, analysis, and interpretation of data, writing of the report, or the decision to submit the report for publication.